# K042208: Isis Mer System/Elekta Mer System

- Pathway: 510(k) (Traditional)
- Applicant: Inomed Medizintechnik GmbH
- Decided: Mar 18, 2005 after 214 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970943 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970943: Guideline System, Axon Instruments, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K944574: Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-in-Space, 6000, Mri), Lumex, Inc. (1994). Our OCR of the scanned summary read K944574, FDA’s number for Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000… (Lumex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Keypoint / Leadpoint system”. Kept off the family tree. Summary page 1.

## Indications for use
The ISIS MER System/ Elekta MER System is intended to be used during neurosurgery to record and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

Source page: https://510kreport.com/device/K042208
Methodology: https://510kreport.com/methodology